NCT05177965已完成不适用
The Metabolic and Circadian Effects of Shift Work - An Observational Study
Tinh-Hai Collet, MD1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Difference in glucose excursion
研究概览
简要总结
In an exploratory observational pilot study, the investigators will focus on the effects of short-term circadian misalignment induced by shift work on multidimensional measurements including glucose excursion, metabolic health, circadian rhythms (measured in vitro and in vivo), sleep/wake cycles and ambient light, eating and activity patterns, well-being and attention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Age 20-50 years
- •Working ≥ 80% full-time equivalent over the previous month and during the study
- •Working night shifts (i.e. shifts that comprise working hours between 23h and 06h) in rotation with day shifts (i.e. shifts that comprise working hours between 06h and 20h)
- •Planned to work at least 3 consecutive night shifts during the study preceded by at least a day off or day shift
- •Planned to work at least 3 consecutive day shifts during the study
- •Confident use of a smartphone compatible with the study application (iOS, Android) and able to regularly take pictures of consumed food/drinks
- •Able to give a fully informed consent and follow the study procedures
排除标准
- •Planned or current pregnancy during the study
- •Menopausal women
- •Major illness or hospitalization over the previous month
- •Carries a pacemaker, pump or other medical device that can be disabled by a magnet
- •Major mental illness
- •Trip to a different time zone (≥ 2-hour time difference) over the previous month or planned during the study
- •Enrolled in an interventional clinical trial (potentially interfering with the main outcomes) over the previous month or planned during the study
结局指标
主要结局
Difference in glucose excursion
时间窗: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by Continuous Glucose Monitoring
次要结局
- Difference in systolic and diastolic blood pressure(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in sleep quality(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in fasting glucose(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in lipid profile(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in blood hormonal profile(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in waist circumference(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in nutrient intake(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in sleep/wake cycles(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in weight(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in eating duration(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in heart rate variability(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in physical activity(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in well-being(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in attention and sleepiness(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
- Difference in mental health outcomes(Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months)
研究者
Tinh-Hai Collet, MD
Principal Investigator
University Hospital, Geneva
研究点 (1)
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